What is the Link Between Pharmacovigilance and Building Confidence Around COVID-19 Vaccines?

Since December 2019, when the SARS-CoV-2 novel coronavirus was first reported in Wuhan, China, the pandemic has infected more than 160 million people and claimed more than 3.3 million lives.

Despite this unprecedented scientific discovery, vaccine hesitancy is seen as a stumbling block towards achieving herd immunity in the battle to control this global pandemic.

In 2019, the WHO identified vaccine hesitancy as one of the top ten global health threats. At the end of 2020, between 37 and 44% of Americans stated that they would not accept a COVID-19 vaccine, whatever the cost. As of March 30, 2021, over a quarter of people living in Europe indicated a hesitancy towards the COVID-19 vaccine with men revealing themselves more hesitant (29%) than women (25%). Concern about safety is the biggest reason for vaccine hesitancy (62%) but 44% of those indicating hesitancy believe the risk of COVID-19 is exaggerated. Remarkably, these figures remain stable over time as it gets more and more difficult to convince the less reluctant populations.

The exceptionally fast pace of development, the seemingly new mRNA technology of some of the vaccines, the accelerated approval process and the mistrustful attitude of the population — perhaps based on the benefit-risk assessment of a healthy population who are being asked to take treatment  —have created a unique regulatory setting where pharmacovigilance and safety have become cornerstone. From the Risk Management Plans (RMPs) of Pfizer, Moderna, Astra-Zeneca and Johnson & Johnson, identified risks are anaphylaxis (Pfizer, Moderna, J&J), potential risks are enhanced respiratory disease (all), nervous system disorders (AZ) and thromboembolism (J&J). Missing information include the use in pregnancy, immunocompromised patients, patients with comorbidities, autoimmune or inflammatory diseases and long-term safety data. Of note, the rates of (re-) infection post-vaccine do not appear in any RMP.

How ICON can provide differentiated service in ensuring vaccine safety:

• Provision of safety monitoring after approval, including:
  • Post-marketed signal detection utilizing MAH specific data and data from public databases, literature
  • Tracking of signals and Risk Minimization Measures
  • Aggregate data review and summary in aggregate safety reports — facilitate drafting and submission
  • Post-authorisation safety studies conducted by the vaccines’ manufacturers, as required by regulators, as well as other longitudinal observational studies that complement knowledge from clinical trials
• Methodology and preliminary results of an in-house study performed in a US claims database that investigated the rates of COVID (re-)infections post-vaccine amongst patients with a critical disease, including the cost by case avoided using the vaccine.

During the COVID epidemic, the pharma industry and the regulatory bodies have demonstrated a remarkable capacity to rapidly develop vaccines, but it has created a situation in which proactive, reactive, innovative safety activities have become a unique, hence, fragile, link between healthcare providers and the population. Using modern technologies and methods is paramount in fulfilling the complete lifecycle of these vaccines and building confidence in our healthcare systems.

Speakers

Florent Richy, Director, Pharmacovigilance & Patient Safety, ICON Plc.

Dr. Florent Richy is an MPH-PhD Pharmaco-Epidemiologist with academic, freelance, pharmaceutical and CRO experience applied to strategic decision making using clinical and real-world evidence data. He has 17 years of experience in the private and public sectors in drug development phases II-IV, HTA, market access, pricing and reimbursement, outcomes research, medical affairs and pharmacovigilance. Florent has been head of various groups of Pharmaco-Epidemiology in the pharmaceutical industry in these environments. He is specialized in strategic evidence generation using observational and/or clinical data to support pharmaceutical and public health questions, including disease history, disease burden, value story generation and pricing, post-authorization commitments, label extensions, safety and benefit risk. Florent has been teaching epidemiology at the University of Liege for the last 15 years and has authored and co-authored more than 50 international peer-reviewed articles and book chapters.

Message Presenter

Bettina Rillmann, Director, Operations, Real World Solutions, ICON Plc.

Bettina Rillmann, Director, Operations, Real World Solutions, ICON Plc., is a specialist in epidemiologic research, with more than 20 years of global operational and strategic experience. She currently provides oversight and direction in the design, analysis, interpretation, and reporting of pharmacoepidemiology studies and serves as a subject matter expert for post-authorization safety studies and drug utilization studies. In addition, Bettina is ICON’s representative at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Message Presenter

Robina Azam, Director, Patient Safety, Pharmacovigilance & Patient Safety, ICON Plc.

Robina Azam, Director, Patient Safety, Pharmacovigilance & Patient Safety, ICON Plc., has over 17 years’ experience in pharmacovigilance inclusive of signal detection/safety surveillance, aggregate reports, risk management and submission-related activities. Experience is inclusive of pre- and post-marketed product, from case processing, clinical study support through to aggregate report generation and signal detection. As a Patient Safety Expert, Bobby provides guidance to project teams and serves as a subject matter expert in safety surveillance and signal detection. She oversees and participates in initiatives to improve these processes, particularly to implement technological solutions to automate processes such as signal detection.

Message Presenter